In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The PMDA operates under the Ministry of Health, Labor, and Welfare (MHLW) .These two government organization both handle a wide range of activities, from approval reviews to post-market surveillance.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing of pre-market approvals directly with the PMDA. Foreign companies shall have partner companies legally constituted in Japan that will be legally responsible for the products imported to and distributed in Japan known as known a Market Authorization Holder (MAH).

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